Re: Bioburden determination
I would like to clarify the following in your question. Bioburden testing
and Microbial limits test are two different tests.
The bioburden test is performed to determine the number of viable
microorganism present in the article irrespective of the type of organism
prior to processing; such as sterilization, filtration, etc, etc.
The Microbial limits is performed to screen for specific microorganisms in
the article that may have harmful effect if consumed. Therefore the
article should be free of these specific organisms; Pseudomonas
aeruginaosa, Staphylococcus aureus, E.coli, Salmonella species.
Now to answer your question; If you are testing microbial limits, it is
always good to follow U.S.P. as precise as possible. There will not be
If you are testing for bioburden limit and using the same criteria as
microbial limits (<10cfu/ml or g), it does not matter what dilution you use
as far as you express the results per g or ml of raw material.
Hope this helps.
Quality Assurance Technical
Alpha Therapeutic Corporation